BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LZA / Polymer Patient Exam Gloves

    Reg #: 3016667413 · FEI: 3016667413 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CONCENTRIC HEALTH ALLIANCE, INC
    Registration Number
    3016667413
    FEI Number
    3016667413
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1100 Peachtree St NE #250
    City
    Atlanta
    State
    GA
    ZIP
    30309
    Country
    US

    Regulatory Submissions

    510(k) Number
    K221229

    Owner / Operator

    Firm Name
    Concentric Health Alliance
    Operator Number
    10066381
    Address
    1100 Peachtree St NE #250
    City
    Atlanta
    State
    GA
    Postal Code
    30309
    Country
    US
    Correspondent
    Amy Holcomb

    Products

    Device Name Product Code
    Polymer Patient Examination Glove LZA
    Latex Patient Examination Glove LYY

    Proprietary Names

    LZA / Polymer Patient Exam Gloves

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198